gmp policy making and dissemination process updates · gmp policy making and dissemination process...

GMP Policy making and Dissemination process updates

Pedro L. Alonso

11 April 2019

Malaria Policy Advisory Committee

Geneva, Switzerland

1

Presentation Outline

1. Brief reminder of rationale and objectives of

the policy review

2. Key findings of the review and choice of focus

areas

3. Key activities started in 2019

4. Detailed update on the GMP Policy Path

5. Key questions for discussion

Why did GMP review its policy making process?

Perceived lack of

transparency and

lengthy process

Inconsistencies in

review standards

Sub-optimal use of GMP

output at country level

4

How the review was

done

Co-constructed with GMP staff & BCG to ensure accurate depiction

Built leveraging previous work on VCAG, I2I

Informed by interviewing 80+ stakeholders across value chain

6

The role of VCAG has become clearer over the past 1.5 years

Procurer

MPAC fulfils its purpose in that it has the highest calibre of technical experts

Procurer

Overall, evidence-based guidelines have been a huge step in the right direction

for WHO

PDP

ERGs have quicker approach for understanding a very specific topic,

gathering best experts, and go in depth on issues. They really expedite and

quality check the process

GMP

WHO website has made good progress & GMP's newsletter is useful

in disseminating new material

Country Programme Manager

It is a good thing GMP produces Guidelines since this gives a framework for use by countries and prevents them from being flooded with products they

won't know what to do with

Manufacturer

Interview consensus: GMP policy making and dissemination process has dramatically improved since introduction of MPAC…

Source: Interviews

Organisation Evidence & Expertise Dissemination

7

…and brings unique value to countries

All countries we work with look at WHO for the last word as per intervention selection

Implementer

WHO is an indispensable partner for low-income countries

Technical Partner

WHO plays an absolute key role in malaria endemic countries

Manufacturer

Analytical framework, 7 focus areas were identified

12

High level diagram of the GMP Policy Pathway – new products(draft in discussion)

2 3 4 5 6 8

Horizon scanning

Product development

PQ Applica

tion

Joint review of application

PQ & Policy recommendation

activitiesImplementation

Mapping of existing TPPs

and development of PPCs/TPPs

based on public health

needs – to steer

innovation

Scientific advice

R&D -Product

development

(external to WHO)

Application submission

for PQ

GMP-PQ Coordination Committee

Evidence review and policy recommendation development activities

GMP

Prequalification assessment

PQ

Support and monitor

implementation/ Post-marketing

surveillance activities

PPC/TPPdevelopment

1

Horizon scanning to anticipate product

pipeline and when evidence is available to

support a policy recom-

mendation

7

Dissemination

Disseminate policy

recommendations & PQ listing

and monitor uptake

9

Feedback loop

Feedback loop from end-users at

country level on policy and

needs

Better Anticipate Develop Policy Optimize Uptake

Open & transparent processSimplified taxonomy

& documentsShortened timelines

Digital dissemination tools

Joint 'go to market' of PQ listing & policy

recommendations for new products1 - Discussion &

agreement with PQ required

Increased coordination between

GMP & PQ

Reg. Auth.

VCAG

Jointly PQ & GMP

Reg. Auth.

Unmet public health needs

• Define the problem (unmet public health needs)

• Define what do we need to solve the problem (PPC/TPP)

• Identify pipeline of new tools and strategies

• Formalize engagement with developers and agree on performance criteria

Unmet and (partially met) Public Health needs related to malaria

Purpose: to frame the prioritization of our work

How: inclusive process with a convening and online consultation

Result:

• Prioritized list of unmet and partially met public health needs related to malaria

• Builds on previous work of malERA and other analyses

• Provides a basis to map existing target product profiles

• Identifies gaps where preferred product characteristics could stimulate innovation

Action:

• Background analyses to inform consensus-building consultation

• Open portal to submit ideas (3 month pilot)

Horizon Scanning – for discussion and input

Purpose: to identify tools/strategies in development to inform the timing for potential policy recommendation development

How: Three key areas to monitor regularly

1. Product development pipelines (human trials?) – with support from product development partners

2. New evidence to update existing recommendations(tools/strategies)

3. Evidence to develop new recommendation – strategies

Preferred Product Characteristics / Target Product Profiles

Understanding product profiles as a continuum

Target Product Profile (TPP)• GMP proposes to collect and lead

review of existing TPPs owned by partners

• Map against unmet/partially met public health needs for malaria to identify gaps

• Use TPPs to have a joint scientific dialogue with developers and PQ to inform performance criteria and evidence required for policy recommendation & PQ listing

Preferred Product Characteristic (PPC) • GMP proposes to lead consensus

development to address gaps • product profile informs product

developers, procurement agencies and funders on R&D and public health priorities

• intended to facilitate product development and evidence generation addressing the greatest and most urgent public health need – products and strategies

16


2 3 4 5 6 8

Horizon scanning

Product development

PQ Applica

tion







needs – to steer

innovation

Scientific advice

R&D -Product

development

(external to WHO)


for PQ



GMP


PQ

Support and monitor



PPC/TPPdevelopment

1




mendation

7

Dissemination

Disseminate policy


and monitor uptake

9

Feedback loop



needs






GMP & PQ

Reg. Auth.

VCAG

Jointly PQ & GMP

Reg. Auth.





• Reduce time from evidence to policy

• Linked policy recommendation & PQ listing

• Clarity on advisory body roles

17

Develop Policy What’s new

Vision:TransparencyConsistency

Coordination Impact

Policy Pathway – Products and Strategies

• Following the standards of the Guideline Review

Committee and Norms & Standards department

• Transparent prioritization of policy development via

MPAC meetings

• Convene single GMP Guidelines Development Group to

ensure consistency and coherence

• Develop guidance on intervention mixes and

prioritisation

• Post review standards on GMP website and track

process steps for transparency

Products only

• Explore using stringent regulatory authority submission

as trigger to begin development of policy

• Contingent on data being made publically available

• Improved coordination between GMP and PQ to

publish simultaneous policy recommendation and PQ

listing for new tools

Advisory bodies – clarifying functions

Malaria Policy Advisory Committee (MPAC)• No change – GMP’s highest level advisory body

Development of Policy recommendations:Guidelines Development Group (3 configurations)• GDG alone • GDG + technical experts• ERG draft + GDG review

*Open call for experts – 30 April deadline for GDG w/ selection by June

2019; remains open for ERGs

Technical advice to GMP: Malaria Elimination Oversight Committee,

Malaria Elimination Certification Panel, Vector Control Advisory Group,

Strategic Advisory Group on malaria eradication, and other ad hoc

technical consultations

GMP Advisory bodies structure

Malaria Policy Advisory Committee

(MPAC)

WHO Director-General

Malaria Elimination Oversight

Committee (MEOC)

Malaria Elimination Certification Panel

(MECP)

Policy

GMP Secretariat

GMP Guidelines Development Group (GDG) + ad hoc ERGs

Advisory

Vector Control Advisory Group

(VCAG) w/ NTD/PQ

Strategic Advisory Group on malaria

eradication

Malaria Vaccine Advisory Committee

(MALVAC) w/ IVB

Other ad hoc technical

consultations

20


2 3 4 5 6 8

Horizon scanning

Product development

PQ Applica

tion







needs – to steer

innovation

Scientific advice

R&D -Product

development

(external to WHO)


for PQ



GMP


PQ

Support and monitor



PPC/TPPdevelopment

1




mendation

7

Dissemination

Disseminate policy


and monitor uptake

9

Feedback loop



needs






GMP & PQ

Reg. Auth.

VCAG

Jointly PQ & GMP

Reg. Auth.





• Simplify taxonomy and structure

• Engage partner and country networks

• Monitor implementation

• Ensure feedback loops to meet end-user needs

Optimize Uptake for Impact

What we heard from National Programmes and their partners:• Difficult to locate relevant information on the GMP website• Hard to understand how the different documents fit together• Documents should be shorter/more concise and have consistency in naming• Preference for digital documents via the website and mobile app; with needs

remaining for printed materials• Insufficient engagement from WHO on new policy at country level• Feedback mechanisms from end-users are needed

3 key levers identified:• Improve structure of documents• Improve GMP website• Develop new sharing opportunities

Country survey conducted to understand barriers to uptake & suggestions for improvement - 96 responses

Optimize Uptake for Impact

How GMP is responding:

1. Improve the taxonomy and structure of GMP documents

2. Develop a compendium of all existing GMP policy guidance to show how the documents fit together – Quick win

3. Redesign the GMP website for accessing policy recommendations and operational guidance with input from end users – NMCP focus group

4. Expanding the World malaria report mobile app to include malaria guidance – December 2019

5. Engage WHO country and region staff in supporting dissemination & monitor uptake

6. Engage all malaria partners in dissemination

Multiple document types to consistent GMP taxonomy

Policy Product• Malaria Guideline – consolidation of all existing malaria policy recommendations• Policy Recommendation – one recommendation/or group on a specific topic (e.g.,

treatment of uncomplicated P. falciparum malaria)• Appendix – annex document containing all supporting evidence, GRADE tables, analyses

and references supporting the recommendation• Operational manual – detailed document providing operational guidance on how to

implement a policy• Accompanying documents – webinars, Q&A, powerpoint slides to help raise awareness and

dissemination a new policy recommendation• Information note – document summarizing WHO’s position on a specific topic

Improved Digital tools: new Policy Process website

Develop a Policy making process website

• To articulate policy process and review standards

• Communicate unmet and partially met public health needs

• Post and update horizon scanning reports for partner use including product pipelines

• Post PPCs and TPPs that are available to be shared

• List topics prioritized for recommendation development and track progress through pathway steps for increased transparency

• Provide a forum for online consultations

• Pilot launched this week with open consultations on unmet/partially met public health needs and nominations for policy recommendations (3 month pilot)

• [email protected]

Improved Digital tools: Policy recommendations and guidance

Redesign the Policy recommendation and guidance dissemination section to facilitate access

• Respond to end-user advice to improve uptake

• Intuitive topic-based navigation to help find relevant information easily

• Options presented to NMCP focus group for input in April

• Consistent with the structure of the Compendium

• Launch of redesigned site June

Energize Dissemination Network

Priority areas of work:• Partner mapping & identification of upcoming meetings

for dissemination opportunities• Mobilize partner networks to support policy

dissemination and uptake• Orientation and engagement of WHO country staff • Engagement with national programme managers• Conduct a follow-up survey:

• Pulse check to see if GMP response meeting needs• Track adoption, implementation and feedback on

current WHO recommendations on malaria;• Identify technical assistance and training needs • Identify barriers to implementation or key challenges

that may need updated policy recommendations • [email protected]